FDA.reportPublic FDA data

NDC 68071-3652-01 - HYDROCHLOROTHIAZIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3652
Requested NDC
68071-3652-01
Package NDCs from labels
68071-3652-1, 68071-3652-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCHLOROTHIAZIDE TABLETS, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-07-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3652-1HYDROCHLOROTHIAZIDE100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3652HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240725_1e02787f-ccb5-abc2-e063-6294a90af7c3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 27 of 27 · 529 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC5eea66bd-589a-45f8-ba2c-dea66a939d592019-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Pharmaceuticals (USA) Inc.ee11db7b-91bd-4231-8783-889d98e4fa322019-02-23Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAmneal Pharmaceuticals LLCc9acbc95-3629-4276-842b-5c074844dba72019-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEExelan Pharmaceuticals Inc.b5a1b38c-0433-4649-a8b0-f72db0a96c452018-12-28Warnings, Adverse reactionsExact identifier
rxcui: 310798
rxcui: 197770
unii: 0J48LPH2TH
GUNA-DIURAMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITUITARY GLAND -Guna spa3f91cd92-eb6d-4bda-9cad-2e11e0b0fbe22018-12-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC61487122-8a94-4ad5-a307-7893e0b7510c2017-10-13Warnings, Adverse reactionsExact identifier
rxcui: 310798
rxcui: 197770
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC2febae4f-836e-4935-bd06-3495f87b3b822017-08-15Warnings, Adverse reactionsExact identifier
application number: ANDA040702
rxcui: 197770
unii: 0J48LPH2TH
Enalapril maleate and hydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDr. Reddy's Laboratories Limiteded4a55a6-cd6a-c74a-cb93-4b45641691a02010-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.